Yes the AGM presentation read well and has obviously got a few going. Much was made of the recent announcement that CxBladder had been included in the NCCN guidelines, and such an inclusion absolutely should.
But read the guidelines and you will find that it wasn’t. No mention of CxBladder at all.
This is what the CEO’s notes said in his AGM presentation:
“Just this month, we were advised that Cxbladder has been included in the latest version of the National Comprehensive Cancer Network (NCCN) Guidelines for Bladder Cancer in the USA…. as an approved clinical intervention for high-risk patients being monitored for the recurrence of urothelial cancer. This is a pivotal commercial outcome for the company with the NCCN Guidelines widely recognised and used as the standard for clinical policy and practice in oncology by clinicians and payors in the USA. To be considered for review and inclusion in the NCCN guidelines requires an extensive portfolio of clinical evidence, a track record of clinical use, and broad adoption by physicians.”
The market announcement said
CXBLADDER INCLUDED IN THE LATEST NCCN BLADDER CANCER GUIDELINES IN THE USA Cancer diagnostics company, Pacific Edge (NZX: PEB), advises that Cxbladder has been included in the latest version of the National Comprehensive Cancer Network (NCCN) Guidelines for Bladder Cancer in the USA. This is a significant achievement with the NCCN Guidelines widely recognised and used as the standard for clinical policy and practice in oncology by clinicians and payors in the USA. The new guidelines update, which was issued on 10 July 2019, state that the evaluation of urinary urothelial tumor markers (Cxbladder by direct reference) may be considered during surveillance of high-risk non-muscle-invasive bladder cancer. The NCCN Bladder Cancer Panel considers this a category 2B recommendation, which means there is NCCN consensus that the use of Cxbladder as a clinical intervention is appropriate. This follows on from Cxbladder’s inclusion in clinical guidelines by several New Zealand public healthcare providers in the last year. To be considered for review and inclusion in the NCCN guidelines requires an extensive portfolio of clinical evidence, a track record of clinical use, and broad adoption by physicians. This is an important milestone for Pacific Edge’s commercial journey in the USA, says CEO, David Darling, and comes on the back of 10 years of successful clinical evidence and commercial development. “Over the preceding years many of our customers in the USA have been hampered in their commercial use of Cxbladder while the Cxbladder technology has not been specifically included in the guideline recommendations. Inclusion in the NCCN Bladder Cancer guidelines is a major commercial milestone for the Company in the USA and will be of significant value as we progress our commercial discussions with our many urologist customers including the large healthcare organisations we are targeting.”
To me this reads as if the NCCN are recommending the use of CxBladder and have included in the Clinical pathway, no?
But cystoscopies and cytology are still the go if I understand it correctly. The only change is the small print, Urinary Tumour Markers may now be considered in the surveillance of High Risk, non – muscle invasive bladder cancer (only). And this a low evidence level category 2b recommendation. In support of this the NCCN then references a literary study completed in 2015 by Chow et al in support of this and here is the abstract:
https://www.ncbi.nlm.nih.gov/pubmed/26501851
THE PURPOSE:
To systematically review the evidence on the accuracy of urinary biomarkers for diagnosis of bladder cancer in adults who have signs or symptoms of the disease or are undergoing surveillance for recurrent disease.
THE CONCLUSION:
Urinary biomarkers miss a substantial proportion of patients with bladder cancer and are subject to false-positive results in others. Accuracy is poor for low-stage and low-grade tumors.
Cxbladder was considered but with only one study found they found the precision “imprecise” and the strength of evidence “low”.
So this is what PEB mean when they say the NCCN state that the evaluation of urinary urothelial tumor markers (Cxbladder by direct reference) may be considered during surveillance of high-risk non-muscle-invasive bladder cancer.
I think it is very misleading and excitement needs to be kept in check.
Originally Posted by psychic
Reply With Quote
Bookmarks